MAUDE Adverse Event Report: ASAHI INTECC GLADIUS MONGO 14; GUIDE WIRE

Catalog Number	AP14R023P
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In previous report #56898, a second gladius mongo 14 was used to attempt to cross the cto.This wire experienced a broken tip, was retrieved and removed from the patient.This is additional information received today and unknown in previous report.Patient stable and recovered according to normal protocol.

• Brand Name: GLADIUS MONGO 14
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 22542399
• Report Number: 3004718255-2025-00389
• Device Sequence Number: 12512777
• Product Code: DQX
• UDI-Device Identifier: 04547327123693
• UDI-Public: (01)04547327123693(17)271031(10)241126A291
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2025
• Report Date (Section F): 07/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AP14R023P
• Device Lot Number: 241126A291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/01/2025
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/18/2025